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Which Ventilatory Strategy is Better for Lung in Upper Abdominal Surgeries?

Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04872361
Enrollment
117
Registered
2021-05-04
Start date
2021-05-01
Completion date
2022-10-31
Last updated
2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Induced Atelectasis

Brief summary

Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation. Applied PEEP and Recruitment maneuver are thought to enhance lung aeration under general anesthesia which could be assessed by ultrasound.

Detailed description

The aim of our study is to assess the effect of using PEEP with and without recruitment maneuver on atelectasis and lung aeration during open upper abdominal surgeries by ultrasonography. Application of PEEP improves intraoperative oxygenation and thus could minimize the incidence of postoperative atelectasis and respiratory complications during abdominal surgeries. A recent study found that PEEP and RM prevented intraoperative aeration loss, which didn't persist after extubation when comparing effects of positive end-expiratory pressure/recruitment maneuvers with zero end-expiratory pressure on atelectasis during open gynecological surgery by ultrasonography

Interventions

PROCEDURELow PEEP

Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study

PROCEDUREHigh PEEP

PEEP of 10 cm H2O will be applied

PROCEDUREHigh PEEP/RM

PEEP of 10 cm H2O and RM (30 cm H2O for 30 s) immediately after the second lung ultrasonographic examination and repeated every 30 minutes till emergence

DEVICELung ultrasonogrphy assessment

The thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines 1. three or more B lines 2. coalescent B lines 3. consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double-blind (Participant, Outcomes Assessor).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists' physical status grades I, II, and III.

Exclusion criteria

* Patient refusal. * Psychiatric diseases. * Body Mass Index \> 35 Kg/m2. * Previous intrathoracic procedures. * History of severe obstructive pulmonary disease. * History of severe restrictive lung disease. * Pulmonary arterial hypertension ( systolic pulmonary arterial pressure \>40 mmHg). * Pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Pre-emergence LUS scoreintraoperative before recovery from anesthesiaLung ultrasonography score (LUS score) between groups at the end of surgery (just before emergence) as a lower LUS indicates better lung aeration.

Secondary

MeasureTime frameDescription
Heart ratepreoperative, intraoperative for anesthesia duration to 1 hour postoperativeheart rate between groups at each time point of LUS score performance
Mean blood pressurepreoperative, intraoperative to 1 hour postoperativemean arterial blood pressure between groups at each time point of LUS score performance
oxygen saturationpreoperative, intraoperative to 1 hour postoperativepatient oxygen saturation between groups at each time point of LUS score performance
End-tidal carbon dioxide tensionintraoperative for anesthesia durationend tidal CO2 between groups post induction, post recruitment and before extubation
Lung ultrasonography score (LUS score)preoperative, intraoperative for anesthesia duration to 1 hour postoperativeLung ultrasonography score (LUS score) between groups
Arterial partial pressure of carbon dioxide (PaCO2)Intraoperative and 15 min postoperativearterial blood gases post induction, before extubation and at the PACU
PaO2/FiO2Intraoperative and 15 min postoperativearterial blood gases post induction, before extubation and at the PACU
Peak inspiratory pressureintraoperative for anesthesia durationpeak inspiratory pressure between groups after intubation
Postoperative pulmonary complications (PPCs)5 daysPPCs include (pneumothorax, pleural effusion, pulmonary collapse, atelectasis, pneumonia, acute respiratory distress syndrome (ARDS), or pulmonary aspiration).
Arterial partial pressure of oxygen (PaO2)Intraoperative and 15 min postoperativearterial blood gases post induction, before extubation and at the PACU

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026